BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    2.5MM HEX DRIVER/CURVE PASSER/BONE PUNCH/RASP

    K Number: K862689 · Decision Sep 2, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    465
    Registration Numbers
    465
    Same Product Code
    3
    Applicant Total
    163
    Review Days
    49

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    Basic Information

    Device Name
    2.5MM HEX DRIVER/CURVE PASSER/BONE PUNCH/RASP
    K Number
    K862689
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    888.4540
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    W. L. Gore & Associates, Inc.
    Date Received
    July 15, 1986
    Decision Date
    September 2, 1986
    Product Code
    HXX
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HXX Screwdriver

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